Consultancy

M.A.R.C.O.’s expertise was consulted for the planning and execution of many studies including Phase I, II and III trials as well as non-interventional studies.

Additionally, a considerable number of expert reports were provided for various medicinal products and different indications. These included clinical expert reports for regulatory purposes, phase I expert reports for regulatory purposes, and expert reports focusing on pharmacokinetic and/or statistical issues.

Furthermore, M.A.R.C.O. is experienced in the preparation and discussion of protocol outlines for different competent authorities (EMA, WHO, FDA, PMDA – Japan, BfArM, IQWiG). Especially during the last years, M.A.R.C.O. attended several face to face meetings with competent authorities.